Endologix, FDA Delays Nellix EVAS in May, Guidance and Pipeline Review

NEW YORK, NY / ACCESSWIRE / September 27, 2017 / Traders News Source, a leading independent equity research and corporate access firm focused on small and mid-cap public companies is issuing a comprehensive report with no obligation on Endologix, Inc. (NASDAQ: ELGX). The Company's focus is on endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement.

The company developed a minimally invasive, polymer-based system (Nellix EVAS) that completely seals and fills an aortic aneurysm sac while at the same time minimizing device migration. The device has already been approved for sale in the EU since 2013. After that approval, the company continued to develop the Nellix EVAS and subsequently revised its US Premarket Approval application.

However, during May 2017, the company announced that the FDA's response was ultimately more cautious, and after Phase III trials, the FDA decision-making panel held off approving the PMA and requested that Nellix perform a last confirmatory trial. This news was a significant setback for the business risk profile of the company. In fact, the stock fell by more than 30% in response.

What's the current status of Nellix EVAS, and the Company's revised guidance READ MORE

Copy and paste to your browser may be required to view the report - http://tradersnewssource.com/endologix/

On September 11th, ELGX announced that it has signed a joint research and development agreement, as well as an exclusive distribution agreement, with Japan Lifeline Co., Ltd. (JLL) pertaining to the development and distribution of novel endovascular stent graft systems for the treatment of thoracic aortic diseases (the Systems).

Under the terms of these agreements, the two companies will jointly invest in the development, clinical research, and commercialization of the Systems. JLL has exclusive distribution rights to the Systems in Japan, and Endologix intends to commercialize and sell the Systems through its existing global sales force and distribution partners in countries other than Japan.

Our report details the markets for ELGX, their full pipeline, and financial status READ MORE

Copy and paste to your browser may be required to view the report - http://tradersnewssource.com/endologix/

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